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RSS FeedPosted by Michael Wonder on 24 Mar 2021
FDA grants breakthrough device designation to Tempus’ atrial fibrillation ECG analysis platform, developed in collaboration with Geisinger
24 March 2021 - Tempus today announced that the U.S. FDA has granted the company breakthrough device designation for its ECG ...
Posted by Michael Wonder on 24 Mar 2021
Biden’s choice and FDA’s loosening standards of evidence
23 March 2021 - The US Food and Drug Administration is widely considered the world’s premier regulator of drugs and devices, ...
Posted by Michael Wonder on 24 Mar 2021
FDA authorises LetsGetChecked’s home collection coronavirus (COVID-19) test for direct to consumer purchase
24 March 2021 - The direct to consumer test is now authorised by the FDA to sell directly to consumers online ...
Posted by Michael Wonder on 24 Mar 2021
DoorDash launches on-demand delivery of COVID-19 PCR test collection kits through partnerships with Vault Health and Everlywell
22 March 2021 - New partnerships make same-day delivery of FDA authorised COVID-19 test collection kits widely available to consumers across ...
Posted by Michael Wonder on 23 Mar 2021
AstraZeneca vaccine trial data questions raised by US drug agency
23 March 2021 - Promising results announced on Monday from AstraZeneca’s American vaccine trials may have relied on an incomplete ...
Posted by Michael Wonder on 23 Mar 2021
Indian cancer drug manufacturer to pay $50 million for concealing and destroying records in advance of FDA inspection
23 March 2021 - Indian drug manufacturer Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture ...
Posted by Michael Wonder on 23 Mar 2021
Novo Nordisk receives refusal to file letter for once weekly semaglutide 2 mg for the treatment of type 2 diabetes
22 March 2021 - Novo Nordisk today announced that the US FDA has issued a refusal to file letter covering the ...
Posted by Michael Wonder on 23 Mar 2021
Optellum receives FDA clearance for the world’s first AI-powered clinical decision support software for early lung cancer diagnosis
23 March 2021 - Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is ...
Posted by Michael Wonder on 23 Mar 2021
Pacira announces FDA approval of supplemental new drug application for Exparel (bupivacaine liposome injectable suspension) in paediatric patients
22 March 2021 - Exparel is the first and only FDA approved long-acting local analgesic for children aged six and over. ...
Posted by Michael Wonder on 23 Mar 2021
Zealand Pharma announces FDA approval of Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycaemia in people with diabetes
22 March 2021 - Approval based on results from three pivotal trials in adults and children with diabetes, showing median time ...
Posted by Michael Wonder on 23 Mar 2021
FDA approves pembrolizumab for oesophageal or GEJ carcinoma
22 March 2021 - Today the FDA approved pembrolizumab (Keytruda, Merck Sharp & Dohme) in combination with platinum and fluoropyrimidine-based chemotherapy ...
Posted by Michael Wonder on 22 Mar 2021
Oakrum Pharma and Aucta Pharma announce U.S. FDA approval of generic version of Jadenu Sprinkle (deferasirox granules)
22 March 2021 - Oakrum Pharma in collaboration with Aucta Pharmaceuticals announced today the U.S. approval of a generic version of ...
Posted by Michael Wonder on 20 Mar 2021
FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...
Posted by Michael Wonder on 19 Mar 2021
Senate narrowly confirms Becerra as health secretary
18 March 2021 - Republican Sen. Susan Collins joined all of the Democrats present in the 50-49 vote. ...
Posted by Michael Wonder on 19 Mar 2021
Too fast or too slow: is the FDA moving at the right speed?
19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...